Durable ReinforcementThe Zimmer Collagen Repair Patch is a biological

implant consisting of an acellular scaffold of

collagen and elastin, derived from porcine dermal

tissue. The material is purified and cross-linked

through a proprietary process that makes it

resistant to collagenase degradation. The result

is a strong, durable biological implant that is

readily and consistently colonized by host tissue

cells and blood vessels. The implant is provided

in sheet form and is ideal for the reinforcement

of large tendon tears at the repair site.

97-4100-102-00 1112-E06 Printed in USA ©2005, 2006, 2012 Zimmer, Inc.

This documentation is intended exclusively for physicians and is not intended for laypersons.Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects.

Contact your Zimmer representative or visit us at www.zimmer.com

Zimmer® CollagenRepair Patch

Ordering Information

Prod No Description

00-4100-001-00 Zimmer Collagen Repair Patch 1 each, 5cm x 10cm (50 sq. cm) x 1.5mm rectangular sheet

1. Data held on file at Covidien, plc

2. Data on file at Zimmer, Inc.

Manufactured by: Covidien, plcDistributed by: Zimmer, Inc.

A History of Strength and ConsistencyThis revolutionary material has been available since 1998, and over 100,000 implants have

been used for hernia repair, urological, and gynecological applications. The Zimmer® Collagen

Repair Patch is designed to be durable, for results

that last. It is resistant to degradation and enzymatic

attack. No sensitization, rejection, allergenicity, or

no significant inflammatory response has been

observed in animal testing.1

This unique scaffold has proven to be strong

with good cell infiltration and rapid

revascularization.1 In tensile tests, the

Zimmer Collagen Repair Patch can withstand

a significantly larger load than small

intestinal submucosa (SIS) patches offered

by other companies. This is afforded by a

1.5mm thickness and preservation of the original

collagen structure of the dermis.

Studies of the Zimmer Collagen Repair Patch in

an ovine model of rotator cuff repair provided

evidence of positive and predictable

performance characteristics in

animals. Good strength of repair

and integration with native

tendon tissue were invariably

shown in all animals at 24

weeks.2

Example of native tendon tissue

integration with Zimmer Collagen

Repair Patch at 24 weeks. Histology stained

with H&E, from ovine animal study.2

Patch comesmoist in sterile sealed packaging.

Tissue Healing ResponseIn studies in an ovine model, postoperative inflammatory response, measured by comparison of systemic

fibrinogen levels before and after surgery, has not been observed at various time points (3, 6, 9, 12, 24 weeks)

postop.1

There is reduced risk for cross-infection or rejection as lipids, non-collagenous proteins, and cellular material

are removed during the manufacturing process. The implant gradually becomes integrated with the surrounding

tissue, providing strength and contour support. Animal studies show evidence of early cellular infiltration and

new blood vessel formation as early as 2 weeks postop.1

Cross-section of material through a natural pore shows depth of cellular penetration.

Cross-section of material in subcutaneous rat model shows cellular infiltration and neovascularization. Fibroblast growing on collagen.

Zimmer Collagen Repair Patch is collagen in its native state.

Step 1After inspection of the rotator cuff tear,

place stay sutures to provide traction

and assess tendon mobility and quality.

Releases of the rotator cuff tendon

should be performed on the superior

and posterior capsule off the labrum,

and the supraspinatus should be

released from the coracoid base. Any

subacromial space adhesions should

be lysed. With the stay sutures in the

tendon edge, there should now be a

bounce to the tendon and the ability to

mobilize it to the anatomic neck. Very

minimal if any tendon debridement

should be performed.

Step 2The footprint of the rotator cuff should

be scarified with a ronguer or curette;

a trough is not recommended. Suture

holes are established with a curved,

penetrating awl. In this way the holes

can be staggered along the footprint.

Step 3Using a trocar needle, permanent #2

braided nylon sutures are placed through

the bone tunnels. (A Richard-Allan Mayo

trocar needle #217001 is recommended).

Load 2 sutures onto 3 of the 4 bone tunnel

passes, allowing 3 sutures to remain

available for attachment of the Zimmer

Collagen Repair Patch. More sutures may

be necessary for rotator cuff repair, but 3

bone sutures are recommended for

Zimmer Collagen Repair Patch to allow

good fixation for any size tear. Suture

anchors may be utilized, but bone tunnels

are preferred.

Step 4Repair the rotator cuff tendon with

the bone tunnel sutures, using as

many bone sutures as needed.

Place sutures in the rotator cuff interval

to close the supraspinatus to the

upper subscapularis.

Step 5Fashion the size and shape of the

implant, making sure to cut it slightly

larger than necessary, leaving some

extra material to be trimmed away after

suturing. It is recommended to use a

curved apex triangular shape for fit,

covering medially but avoiding the

coracoid and spine of the scapula.

[Approximately 3cm lateral and 3-4cm

in length, depending upon the size of

the patient and tear.]

Step 6Apply and suture the Zimmer Collagen

Repair Patch to the rotator cuff. First

affix the graft at the apex with a

vertical mattress suture if possible.

This is accomplished with a stout

small tapered Mayo needle. It can be

easiest to attempt to place the sutures

through the natural follicles present

in the implant. Next place 2 simple

sutures anterior to and posterior to

the apex suture, and 2 simple sutures

on the anterior and posterior edges.

These should be placed prior to final

repair to the greater tuberosity.

Step 7Utilizing the 3 previously placed bone

sutures, secure the Zimmer Collagen

Repair Patch to the greater tuberosity

with simple sutures. These bone

sutures should pull the graft in light

tension. Trim any unstable edges or

corners after repair.

Step 8Due to the large, massive, or revision

nature of the rotator cuff tear, this is

a vulnerable tendon. It is recommended

that an abduction type pillow be used

for 6 weeks. The goal is a healed

rotator cuff repair.

Indications for Use

Zimmer Collagen Repair patch is intended for the reinforcement of soft tissues repaired by suture or anchor sutures during rotator cuff repair surgery.